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A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00994123
First received: October 13, 2009
Last updated: July 12, 2016
Last verified: July 2016
  Purpose
A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: MM-121
Drug: Erlotinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC. [ Time Frame: From date of first dose to 30 days after termination, the longest 175 weeks ] [ Designated as safety issue: Yes ]
    To establish the safety of escalating doses of MM-121 in combination with erlotinib in order to determine the recommended phase 2 dose of the combination for the second part of the study. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.

  • Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities [ Time Frame: From date of first dose to 30 days after termination, the longest 175 weeks ] [ Designated as safety issue: Yes ]

    Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs.

    The determined MTD was used as the recommended Phase 2 dose.


  • Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination [ Time Frame: Time from first dose to date of progression, with a median of 8.1 weeks ] [ Designated as safety issue: No ]
    This was a time-to-event measure using Progression-Free Survival (PFS) comparing MM-121 + erlotinib vs.erlotinib alone. Progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of weeks from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).


Enrollment: 162
Study Start Date: February 2010
Study Completion Date: June 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1: Dose-Escalation
Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)
Drug: MM-121
MM-121 (SAR256212) = intravenous solution
Other Name: SAR256212
Drug: Erlotinib
erlotinib = daily oral tablet
Other Name: Tarceva
Active Comparator: Phase 2: Control
Erlotinib (daily)
Drug: Erlotinib
erlotinib = daily oral tablet
Other Name: Tarceva
Experimental: Phase 2: Treatment
MM-121 (QOW IV) and erlotinib (daily PO)
Drug: MM-121
MM-121 (SAR256212) = intravenous solution
Other Name: SAR256212
Drug: Erlotinib
erlotinib = daily oral tablet
Other Name: Tarceva

Detailed Description:

Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.

Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with locally advanced or metastatic non-small cell lung cancer.
  • Patients must be >/= 18 years of age.
  • Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.

Exclusion Criteria:

  • Patients with a recent history (within 5 years) of another malignancy.
  • Patients who are pregnant or nursing.
  • Patients with clinically significant heart failure.
  • Patients with clinically significant eye or gastrointestinal abnormalities.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994123

  Show 38 Study Locations
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
  More Information

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00994123     History of Changes
Other Study ID Numbers: MM-121-01-101 
Study First Received: October 13, 2009
Results First Received: February 14, 2016
Last Updated: July 12, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
Non-Small Cell Lung Cancer
NSCLC
Advanced Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer
Lung Cancer
Erlotinib
Tarceva
MM-121
ErbB3
Her3
Epidermal Growth Factor Receptor
anti-ErbB3 human monoclonal antibody
ErbB3 antagonist

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016